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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 2121IQ / 3131IQ

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 Class 2 Device Recall Innova 2121IQ / 3131IQ see related information
Date Posted November 09, 2009
Recall Status1 Terminated on December 03, 2015
Recall Number Z-0138-2010
Recall Event ID 52056
510(K)Number K060259  K061163 
Product Classification Cardiovascular Imaging System - Product Code JAA
Product Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
Code Information SYSTEM ID:

0847160005
542120XR02
561548BIP
561881BP1
630856H3131
817465AR3131
985867INNOVA31
COR373301
EG1000VA01
LY1086VA01
M4166990

05448VAS01
VAD2121
YE1002VA01
YV0365

NOT LOCOLIZED
S/N CHILLER
798080-21
796259-09
794637-08
795371-01
796133-12
796259-05
796464-08
796464-13
796464-15
796767-05
796941-03
796941-04
796941-07
796941-09
797178-05
797179-03
797179-08
797179-12
797449-03
797449-06
797632-02
797812-04
797812-09
797812-10
797812-12
767326-03
770355-02
772153-13
767746-05
785678-16
794637-11
799172-07
799347-03
799347-05
796260-01
783679-01
797178-03
797179-07
797179-09
797179-11
797812-14
797812-16
799347-02
798449-01
798449-02
798449-03


Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra
FDA Determined
Cause 2
Device Design
Action Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Quantity in Commerce 15 AND 46 UNLOCATED
Distribution Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE MEDICAL SYSTEMS, LLC
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